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mTOR inhibitor
Rapamune for Cognitive Impairment (CARPE_DIEM Trial)
Phase < 1
Waitlist Available
Led By Mitzi Gonzales, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8 weeks
Awards & highlights
CARPE_DIEM Trial Summary
This trial will evaluate if Rapamune can penetrate the central nervous system and if it is safe and tolerable for older adults with MCI or early AD.
Who is the study for?
This trial is for older adults with Mild Cognitive Impairment or early Alzheimer's Disease who have stable blood cell counts and are on a steady dose of AD medications. Participants need an authorized representative for consent and must be available for all study visits. Exclusions include diabetes, poor wound healing, substance abuse, certain medication use, recent cancer treatments, liver or lung disease, heart failure, pregnancy, recent severe cardiovascular events.Check my eligibility
What is being tested?
The trial tests the effects of Rapamune (RAPA) on cognition in patients with cognitive impairment due to MCI or early Alzheimer's. It aims to assess how well RAPA enters the brain and its safety and impact on cognition and daily functioning as initial proof-of-concept.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of Rapamune may include mouth sores, diarrhea, increased risk of infection due to immune system suppression; it can also affect blood pressure and kidney function.
CARPE_DIEM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood Brain Barrier Penetration of RAPA
Secondary outcome measures
Adverse Events
Benson Figure Copy
Change in CSF A Beta-42 Levels From Baseline to 8 Weeks
+5 moreSide effects data
From 2014 Phase 1 & 2 trial • 30 Patients • NCT0028615660%
Nonserious infections
60%
Oral ulcerations
40%
Miscellaneous/other
30%
Gastrointestinal symptoms
10%
Decrease visual acuity
10%
Edema
10%
nephrotic range proteinuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Rapamycin Dose (STD)
Low Dose Rapamycin (LD)
Standard Care
CARPE_DIEM Trial Design
1Treatment groups
Experimental Treatment
Group I: RAPA interventionExperimental Treatment1 Intervention
Sirolimus 1mg orally once a day for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rapamune
2020
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
National Center for Advancing Translational Sciences (NCATS)NIH
324 Previous Clinical Trials
401,616 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
454 Previous Clinical Trials
90,766 Total Patients Enrolled
Mitzi Gonzales, PhDPrincipal InvestigatorUT Health San Antonio
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently use tobacco, illegal drugs, or drink alcohol excessively.You are taking blood-thinning medications other than aspirin.You are taking medications that can affect the way your body processes other drugs.You have diabetes with high HbA1c levels or are taking medication for diabetes.You have had skin ulcers or problems with healing wounds in the past.Your blood cell counts are within the normal range and have not shown any significant changes.You currently have liver disease or any known liver or bile duct problems.You have taken medication that weakens your immune system in the past year.You have received chemotherapy or radiation treatment in the past year.You have a current or ongoing lung disease or low oxygen levels in your blood.You have long-term heart failure.You had a heart attack, heart disease, stroke, or other serious heart or intestinal problems in the last 6 months.You have a major neurological condition other than Alzheimer's disease.Your blood pressure is not well controlled and is consistently too high.You have a current health condition like inflammation, infection, or mental illness that is not well controlled.You have had a brain scan that showed a growth or other issue that would make it unsafe for you to have a spinal tap.You have been diagnosed with mild cognitive impairment or have certain memory test results that show impairment, as confirmed by a clinician.
Research Study Groups:
This trial has the following groups:- Group 1: RAPA intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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